<p><span lang="EN-GB">This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.</span></p>
<p><span lang="EN-GB">EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment</span><span lang="EN-GB"> </span><span lang="EN-GB"> function or humidifier function.</span></p>
<p><span lang="EN-GB">EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.</span></p>
<p><span lang="EN-GB">EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases</span><span lang="EN-GB">[2]</span><span lang="EN-GB">. </span></p>
<p><span lang="EN-GB">EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.</span></p>
<p><span lang="EN-GB">NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.</span></p>
<p><span lang="EN-GB">This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.</span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</span></p>
<p><span lang="EN-GB">NOTE 3</span><span lang="EN-GB"> </span><span lang="EN-GB">See also 4.2 of the general standard.</span></p>
Registration number (WIID)
87164
Scope
<p><span lang="EN-GB">This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.</span></p>
<p><span lang="EN-GB">EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment</span><span lang="EN-GB"> </span><span lang="EN-GB"> function or humidifier function.</span></p>
<p><span lang="EN-GB">EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.</span></p>
<p><span lang="EN-GB">EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases</span><span lang="EN-GB">[2]</span><span lang="EN-GB">. </span></p>
<p><span lang="EN-GB">EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.</span></p>
<p><span lang="EN-GB">NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.</span></p>
<p><span lang="EN-GB">This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.</span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</span></p>
<p><span lang="EN-GB">NOTE 3</span><span lang="EN-GB"> </span><span lang="EN-GB">See also 4.2 of the general standard.</span></p>
